Regulatory 20389-MZ

Job Title: Regulatory Executive Senior

Where: King of Prussia, PA

Hours: 8/day, 40/week

Contract: 11 months

Position Description

This position will be directly responsible for managing CMC responses to marketing applications for a biopharmaceutical product in US, EU, Japan, and ROW markets. The individual will work collaboratively and proactively within the CMC project team and across multiple functional areas to manage the response activities to develop the strategy, scope, and content of the CMC sections of the responses.

Position Responsibilities

Provide guidance to functional area authors/reviewers with regards to submission and dossier requirements. Understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biopharmaceutical products.

Work closely with project team members and CMC regulatory team to produce high quality submissions.

Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes. Effectively adjust plans to deal with changes and obstacles.

Identify, document, and communicate regulatory project risks that could impact timeline and quality of regulatory submissions.

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